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Atrial FibrillationNCT04123327

Symptom Preoccupation in Atrial Fibrillation (AF) and Its Role in AF-related Disability

An observational study of Atrial Fibrillation, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A cross-sectional study (N=400) will investigate the prevalence of symptom preoccupation and its role in AF-related disability. Subjectively-rated assessments will be gathered from 400 AF patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
How many people
400 participants
Where
1 siteSweden
Study dates
24 Dec 2019to 10 Oct 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients above 18 years of age and diagnosed with AF (paroxysmal, persistant or chronic)

Who may be able to join

  • 18 years of age
  • Diagnoses with AF
  • Able to read Swedish and access to computer

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Department of Clinical Neuroscience, Karolinska Institutet

    Stockholm

Other trials in Sweden

About this study

Official title: The Prevalence of Symptom Preoccupation and Its Role in AF-related Disability

A cross-sectional study (N=400) will investigate the prevalence of symptom preoccupation and its role in AF-related disability. Subjectively-rated assessments will be gathered from 400 AF patients.

Read the detailed description

In the present study we aim to investigate symptom preoccupation in patients with atrial fibrillation (AF) to further improve the understanding of the role of psychological factors in AF-related disability. A cross-sectional study (N=400) will investigate the prevalence of symptom preoccupation and its role in AF-related disability. Subjectively-rated assessments will be gathered from 400 AF patients.

Keywords
Symptom preoccupation, Atrial fibrillation, Quality of Life, Cardiac anxiety
Medical subject headings
Atrial Fibrillation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. [Time Frame: From baseline to 12 weeks] Atrial Fibrillation Effect on Quality-of-Life (AFEQT)

    AFEQT is an atrial fibrillation-specific measure that taps into the QoL-domains: symptoms, daily activities, treatment concern, and treatment satisfaction. The scale has 20 items, with the total score ranging from 0 (severe symptoms and disability) to 100 (no symptoms and disability), with responses provided on a seven-point rating scale from "no limitations/symptoms" to "severe limitations/symptoms".

    Measured: Baseline

Secondary outcomes (12)

  1. Cardiac Anxiety Questionnaire (CAQ)

    It an 18-item scale that measures cardiac anxiety by three subscales fear (e.g., "When my heart is beating fast I get frightened" avoidance (e.g., I avoid exercise or other physical work) and attention (e.g., I pay attention to my heart beat). The responses are given on a four-point Likert scale ranging from 0 (never) to 4 (always), a greater score indicates greater cardiac anxiety.

    Measured: Baseline

  2. Patient Health Questionnaire (PHQ-9)

    Measures depressive symptoms on nine items scoring from 0 (not at all) to 3 (nearly every day) per item. Scores were categorized as follows: zero to minimal depressive symptoms (0-4), mild to moderate depressive symptoms (5-10), or severe depressive symptoms (10 or above).

    Measured: Baseline

  3. The Generalized Anxiety Disorder (GAD-7)

    The Generalized Anxiety Disorder (GAD-7) scale measures the severity of worry and anxiety. In healthy controls, the mean score was 4.9 (SD=4.8); a score of 10 or greater on the scale corresponds to a cut-off point for identifying cases of GAD.

    Measured: Baseline

  4. Anxiety Sensitivity Index (ASI)

    Measure of anxiety sensitivity

    Measured: Baseline

  5. Bodily Sensation Questionnaire (BSQ)

    Fear of bodily sensations

    Measured: Baseline

  6. The University of Toronto Atrial Fibrillation Severity Scale (AFSS)

    AFSS will assess AF symptoms and how affected the patient is by AF-specific symptoms such as dyspnea, palpitations etc. The AF symptom score ranges from 0-35 with a higher score indicating higher symptom severity.

    Measured: Baseline

  7. The Symptoms Checklist, Frequency and Severity Scale (SCL)

    SCL is a disease specific checklist used to measure AF-related symptoms (e.g., palpitations, dizziness) on two subscales: symptom severity (mild to extreme; 16 items, scores ranging from 0 to 48) and symptom frequency (never to always; 16 items, scores ranging from 0 to 64) over the past four weeks. Higher scores correlate with more frequent and severe symptoms.

    Measured: Baseline

  8. Perceived Stress Scale (PSS-4)

    To assess stress sensitivity and perception of stress. Each item is rated on a five-point scale and a higher score corresponds to more perceived stress.

    Measured: Baseline

  9. World Health Organization Disability Assessment Schedule (WHODAS)

    WHODAS is a reliable and well validated measure of general health and disability. We use the version consisting of 12-items evaluating six domains: cognition, mobility, self-care, getting along, life activities and life participation. Each item is rated on a 5-point scale, with higher scores indicating increased disability.

    Measured: Baseline

  10. AF behaviors

    Checklist of behaviors related to AF

    Measured: Baseline

  11. Demographics

    Demographics

    Measured: Baseline

  12. Medical history

    Comorbidities, medication, medical history

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2019
  2. Study start24 Dec 2019
  3. Primary completion10 Oct 2020
  4. Study completion10 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04123327
Sponsor's protocol ID
Cross-sectional AF
Status last verified
Feb 2020
First submitted
9 Oct 2019
Last updated
18 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

[Time Frame: From baseline to 12 weeks] Atrial Fibrillation Effect on Quality-of-Life (AFEQT) (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04123327.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.

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